Safety and Effectiveness of Bupivacaine Liposome Injection for Pain Relief After Pediatric Orthopedic Surgery in Children Ages 6 to 17

What this Trial Is About

Researchers are evaluating the safety and effectiveness of bupivacaine liposome injection for local pain relief in children aged 6 to 17 undergoing orthopedic surgery. This Phase 4 study focuses on real-world use of this treatment to manage acute postoperative pain. The study is sponsored by Jiangsu HengRui Medicine Co., Ltd. and aims to understand how well this analgesic works and its safety profile in pediatric patients. Participants will receive bupivacaine liposome injection at a dose of 4 mgkg, up to a maximum of 266 mg, applied locally during surgery. The study observes patients from the time of administration through the postoperative period, monitoring pain control and the need for additional opioid pain medications. This is an interventional study without masking or placebo control. During the study, researchers will closely track adverse events related to the heart and nervous system for up to 14 days after treatment. They will measure opioid use, time to first opioid rescue medication, pain scores at rest and during movement for different age groups, and length of hospital stay up to two weeks. Participants will undergo regular assessments to evaluate pain relief and safety throughout the 72-hour postoperative period and beyond.

A Study of Bupivacaine Liposome Injection in Local Analgesia of Pediatric Patients